Accessing and deaccessing tools and methods

ABSTRACT

A tool is used to assist in the manual insertion and removal of a needle into a medical device implanted under the skin of a patient. The tool includes an elongated body having a handle section and an enlarged guard section with an elongated slot extending from an edge of the guard section into the guard section, terminating at an internal portion of the guard section. Preferably, the guard section of this tool is transparent, and it has indicia thereon which assist in aligning the tool with the implanted medical device. The guard section may include a depression on its underside which overlies the implanted medical device when the guard is placed in position for accessing or deaccessing the needle.

RELATED PATENT APPLICATIONS

This application is a continuation-in-part application of U.S. Ser. No.08/653,305, entitled “Accessing and Deaccessing Tools & Methods,” filedMay 24, 1996, now U.S. Pat. No. 5,797,954.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to tools and methods for accessing anddeaccessing a medical device implanted under the skin of a patient, andparticularly tools and methods which reduce the risk of a nurseaccidentally sticking herself or himself or a patient with a needle.

2. Background Discussion

Implanted medical devices, such as vascular access devices, are commonlyused to allow medication to be administered to patients. One suchimplant device is sold under the trademark “BardPort” by C. R. Bard,Inc. These devices include a housing enclosing a chamber which has aninlet covered with a silicone or latex seal. An outlet in communicationwith the chamber allows fluid in the chamber to flow through the outletinto a tube which, typically, is inserted into the vein of a patient.

These devices are accessed periodically by a nurse who inserts a needlethrough the patient's skin overlying the device and then into andthrough the seal. The nurse palpates, or feels, the device through theskin overlying the implanted device, and presses downward to locate theposition of the implanted device. While holding or pressing against thedevice through the skin with one hand, the nurse with the other handinserts the needle through the skin, and into and through the seal. Onceproperly inserted through the skin, the tip of the needle penetrates theseal and is lodged within the chamber. A “click” sound can sometimes beheard when the tip of the needle touches the bottom of the chamber, orthe nurse can feel the tip contact the bottom of the chamber. Typically,the needle penetrates a depth of from about ¼ inch to about 1 inch.Medication now flows through the needle into the chamber and then outthe outlet through the tube into the vein of the patient. Sometimes,however, the nurse, while attempting to introduce the needle into theseal of the implanted device, accidently sticks herself or himself withthe needle. These accidental needle sticks occur while either accessingor deaccessing the implanted device with the needle.

Needle sticks occur most frequently while deaccessing the needle. Theneedle sometimes remains in the implanted medical device for severalhours, and sometimes even for several days.

These needles must be periodically flushed and removed from the device.The removal is accomplished by the nurse, with one hand, pressingagainst the skin overlying and around the device, and, with the otherhand, grasping the needle and withdrawing it from the device.Frequently, there is an involuntary muscular recoil as the needleescapes from the implanted medical device as it is withdrawn. It isthought that this recoil is due to proprioceptive neuro-muscularactivity. The recoil sometimes results in the nurse accidentallysticking a finger of the hand which is pressing against the skinadjacent to the implanted medical device. If the source patient has aninfectious and or contagious disease such as disseminated TB, HepatitisB or C, or is HIV positive or has AIDS, the nurse may contract thedisease directly from this needle stick.

After such a needlestick, even if the source patient has no communicableand/or infectious disease or condition identified at the time of theneedlestick, the nurse must undergo intensive and expensive follow-uptesting intermittently for up to 1 year. The source patient must betested, if they consent, for infectious or communicable disease as setforth in the OSHA regulations and CDC (Center for Disease Control)recommendations, under Employee Exposure to Bloodborne Pathogens. Thenurse must also be counseled as to certain restrictions in his or herown lifestyle, particularly sex practices, until his or her own freedomfrom communicable/infectious disease or condition is determined. Thisplaces an incredible strain on the nurse's marital relationships andlifestyle. The partner often demands that the nurse quit nursing ratherthan face the risks.

Needle sticks also occur while accessing the implanted device. Theproblem of contracting an infectious, contagious disease also issometimes encountered. For example, the needle, which is typicallysterile initially, has in some reported instances completely penetratedthe finger of the nurse and entered the body of the patient. The nowcontaminated needle can only be removed by withdrawing it from thepatient's body into and through the nurse's finger, possibly infectingthe nurse.

Recent guidelines promulgated by the CDC prohibits medical acts whichrequire manipulating needles using both hands in the act, or any othertechnique that involves directing the point of a needle toward any partof the health care workers body. Under the current protocols for usingthe implanted device, the nurse's hand which secures the implanteddevice in place during accessing and deaccessing is always in directline with the needle during accessing, and also in line with the needletip during deaccessing when one considers the frequency of the knownrecoil phenomenon.

The problem of needle sticks while deaccessing the needle has beenrecognized by workers at the University Hospital in Antwerp, Belgium,who published an article in Infection Control and Hospital Epidemiology,Volume 14, No. 10 (October 1993). In this article it is suggested to usea tool, rather than the nurse's hand, to hold the implanted deviceduring removal of the needle. The suggested tool includes a guard with aslot in it. The guard has a relatively small area. It appears to be lessthan 1 square inch, and it appears to be made of an opaque material.There is a short handle attached to the guard used to grasp the toolwhich does not permit the hand of the nurse to be located far enoughaway from the needle to insure avoiding needle sticks if a recoiloccurs.

SUMMARY OF THE INVENTION

It is the objective of this invention to provide tools and methods whichallow a nurse to access and deaccess safely a needle used with animplanted medical device. This invention has several features, no singleone of which is solely responsible for its desirable attributes. Withoutlimiting the scope of this invention as expressed by the claims whichfollow, its more prominent features will now be discussed briefly. Afterconsidering this discussion, and particularly after reading the sectionentitled, “DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS,” one willunderstand how the features of this invention provide its benefits,which include low cost manufacture, simplicity of use, and, mostimportantly, nurse and patient safety by avoiding accidental needlesticks and the ensuing medical costs and risks such as, for example,loss of health or life, ability to work, and sometimes spousal support.

The first feature of the tool of this invention is that it may be usedfor assisting in both accessing and deaccessing a needle used with amedical device implanted under the skin of a patient. In one embodimentit has the general configuration of a spatula and it includes anelongated body having a handle section and an enlarged guard section.There is an elongated slot extending from an edge of the guard sectioninto the guard section, terminating at an internal portion of the guardsection. The guard section has an area of 1.00 square inch or more,typically the area is from about 1.00 square inch to about 18 squareinches. This relatively large guard area prevents the patient from beingstuck with the needle, if there is a recoil during removal of the needlefrom the implanted medical device.

The second feature is the dimensions and other physical characteristicsof the guard section. The guard section has a forward edge terminatingat opposed ends and side edges at each opposed end which extend rearwardto the handle section. The guard section has a floor including theforward edge, opposed sides, and a rear end. There is a raised rear wallconnected to the rear of end of the floor, and a pair of raised sidewalls, each connected to one side of the floor. Preferably, the sidewalls taper down from their highest distance above the floor near therear end to essentially level with the floor near the forward edge. Theforward edge has a length of from about 1 to about 6 inches. The sideedges have a length of from about 0.5 to about 3 inches. The guardsection has a smooth, generally planar underside surface and a thicknessof from {fraction (1/32)} to {fraction (3/16)} inch. The walls have amaximum height of about ¼ inch.

The third feature is the dimensions and other physical characteristicsof the slot. The slot extends from an edge of the guard section inward adistance in excess of ¼ inch, preferably having a length of from about0.25 to about 3 inches, and it has a width that is slightly broader thanthe diameter of the needle, typically from about {fraction (1/16)} toabout ¼ inch. Preferably, the slot is at a right angle with respect tothe forward edge, and the slot and the handle section are in substantialalignment with each other, both lying along a common longitudinal axis.Preferably, the minimum distance between the slot and a side edge isabout {fraction (3/16)} inch and the maximum distance between the slotand a side edge is about 3 inches. The elongated slot preferably hastapered edges. These tapered edges assist in removal of the needle fromthe implanted medical device.

The fourth feature is that the guard section is made of a transparentmaterial. In most instances the entire tool is injected molded from apolymeric material such as, for example, polypropylene homopolymer or apolycarbonate, sold under the trademark LEXAN by General Electric, Inc.Because the guard section is transparent, the nurse may more easilyalign the tool with the implanted medical device. This is especiallyadvantageous during accessing the implanted device. In one embodimentespecially designed to assist in accessing the implanted device, theslot has along it's length an enlarged open portion with an area inexcess of 0.0036 square inch. Preferably, the open portion is circularhaving a diameter greater than {fraction (1/16)} inch, typically from ⅛to ¼ inch. The nurse inserts the needle through this enlarged openportion when accessing the implanted medical device. Preferably, theenlarged open portion is about midway between the forward edge and thebite of the slot. Preferably, there are indicia on the guard sectionwhich assist the nurse in aligning the guard section with the implantedmedical device during accessing. For example, there may be a pair ofmarks on the guard disposed along the slot which are spaced apart adistance approximately equal to the width of the implanted medicaldevice, typically from ¾ to 1 ½ inch. Alternately, the indicia may be atleast partially encompassing the enlarged open portion along the slot.For example, the indicia may be a circle with its center coincident withthe center of the enlarged circular open portion.

The fifth feature is that the tool is designed to enable the nurse tokeep his or her hand a safe distance away from the needle during removalof the needle from the implanted device. The tool typically has a lengthof from 3 to 11 inches, and the handle section typically has a length offrom 3 to 8 inches. The handle section has an elongated depressiontherein extending lengthwise along this handle section into which thethumb is placed during use. This depression provides a lever platform toenhance manipulative control of the tool. Thus, even someone with poorfinger dexterity may easily manipulate the tool of this invention. Inthe preferred embodiment of this invention, the handle section has amarker on it indicating that the hand of the nurse should be behind thismarker. The marker is at a distance to position the hand of the nursesafely away from the point where the needle is inserted into theimplanted medical device. This distance is at least 2.5 inches away fromthe end of the slot terminating at an internal portion of the guardsection. The handle section may include an intermediate neck section,and the guard section is joined to the intermediate neck. The handlesection and the intermediate neck are at an acute angle of from 0 to 20degrees, and the intermediate neck section and the guard section are atan acute angle of from 10 to 40 degrees. There may be a receptaclemember on the elongated body in which a needle extracted from theimplanted device may be inserted.

The sixth feature is that a special tool is provided for assisting inthe manual insertion of a needle into the implanted medical device of apredetermined width. This tool includes a handle section and a holdersection, with the holder section having a pair of fork elements spacedapart a distance which is slightly greater than the width of the medicaldevice. Typically, this distance is from about ½ inch to about 2 inch.The fork elements are of equal length, each having a length of fromabout 0.5 inch to about 3 inch. The holder section has a length of from0.5 to 3 inches and the handle section has a length of from 3 to 8inches. The longitudinal axis of the handle section bisects the holdersection, with each fork element being equidistance from the longitudinalaxis. The holder section has a smooth, generally planar undersidesurface, and the handle section has a marker thereon indicating that thehand of the nurse should be behind this marker.

The seventh feature is that the handle section and guard section may bedetachable, enabling the guard section to be discarded after use and thehandle section reused. There is a locking mechanism that engages thehandle section upon inserting the handle section into a track on theguard section and a manually releasable element that upon being releasedallows the handle section to be detached from the guard section.

The eighth feature is that the underside of the guard section has adepression therein having a configuration substantially the same as theconfiguration of the medical device, so that when the guard sectionoverlies the implanted medical device and is pressed against theimplanted medical device, the skin of the patient and at least a portionof the medical device are received in the depression. Preferably, thedepression is a concave section. Advantageously, the guard section has asubstantially circular configuration with an area of 1.0 square inch,which is slightly larger than the area of the top portion of theimplanted medical device. The area may, however, be greater than 1.0square inches. Preferably, the concave section has a center coincidentwith the center of the guard section and a substantially circular rimwith a diameter of from {fraction (1/16)} to ½ inch, and a depth at thecenter of the concave section from {fraction (1/16)} to {fraction(3/16)} inch. In the preferred embodiment, the handle section and theguard section are molded from a polymeric material as a unitarystructure, and the elongated slot extends radially outward from thecenter of the concave section to a circumferential edge of the guardsection. The handle section has top wall and side walls extending fromthe top wall substantially at a right angle with respect to the topwall, and the marker comprises a raised portion on the top wall thatserves as a thumb lever.

The ninth feature of this invention is that the handle has a connectorsection that is attached to the guard section, forming between thisconnector section and guard section an angle of 60 degrees or more,preferably between about 60 and about 90 degrees. This assists inmaintaining the thumb a safe distance from the needle and creating adownward force applied to the guard section during use of the thumblever.

This invention also includes a number of methods for accessing anddeaccessing the implanted medical device. The first method is formanually removing a needle from a medical device implanted under theskin of a patient. It includes the following steps:

(a) grasping with the one, typically the non-dominant, hand a handlesection of a tool having a guard section having an area of 1.00 squareinch or more and a slot therein,

(b) sliding the slot along the needle to bring the guard section into anoverlying relationship with the implanted medical device,

(c) maintaining the one hand a minimum distance away from the needle ofat least 2.5 inches and exerting sufficient pressure to stabilize theguard area holding the implanted medical device preventing said devicefrom moving,

(d) with the other, typically the dominant hand, withdrawing the needlefree of the implanted medical device.

The deaccessing tool discussed above is used in performing this method.

The second method is for manually inserting a needle into a medicaldevice implanted under the skin of a patient. It includes the followingsteps:

(a) grasping with one hand, typically the non-dominant hand, a tool witha holder section and a handle section, and holding a tool by the handlesection and pressing the holder section against the skin overlying themedical device, and

(b) gripping the needle with the other hand, typically the dominanthand, and inserting said needle through said skin into the medicaldevice, and

(c) maintaining said one hand a distance of at least 2.5 inches awayfrom the needle as said needle is inserted into the medical device.

Either the tool discussed above which is designed especially foraccessing the implanted medical device or the tool for deaccessing theneedle may be used to conduct the second method. It is preferable thatthe guard sections of these tools be transparent and have indiciathereon which assist the nurse aligning the slot with the implanteddevice. These tools with transparent guard sections and indicia thereonmay be used for both accessing and deaccessing the needle.

DESCRIPTION OF THE DRAWING

The preferred embodiments of this invention, illustrating all itsfeatures, will now be discussed in detail. These embodiments depict thenovel and non-obvious accessing and deaccessing tools and methods ofthis invention as shown in the accompanying drawing, which is forillustrative purposes only. This drawing includes the following figures(FIGS.), with like numerals indicating like parts:

FIG. 1 is a perspective view illustrating a nurse being accidentallystuck with a needle that is being removed from an implanted medicaldevice in the conventional manner.

FIG. 2 is a perspective view showing the needle inserted into animplanted medical device in the conventional manner.

FIG. 3 is a cross-sectional view taken along line 3—3 of FIG. 4.

FIG. 4 is a perspective view illustrating using the tool of thisinvention to safely remove a needle from an implanted medical device.

FIG. 5 is a plan view taken along line 5—5 of FIG. 4.

FIG. 6 is a plan view of the tool of this invention.

FIG. 7 is a side elevational view of the tool of this invention.

FIG. 8 is a plan view illustrating a nurse using an accessing tool ofthis invention to hold steady an implanted medical device while a needleis being inserted through the patient's skin into the implanted medicaldevice.

FIG. 9 is a plan view of the accessing tool of this invention.

FIG. 10 is a side elevational view of the accessing tool of thisinvention.

FIG. 11 is a fragmentary plan view of a second embodiment of the tool ofthis invention, showing a modified guard section.

FIG. 12 is a fragmentary plan view of a third embodiment of the tool ofthis invention, showing a modified guard section for a right handednurse.

FIG. 13 is a fragmentary plan view of a fourth embodiment of the tool ofthis invention, showing a modified guard section for a left handednurse.

FIG. 14 is a top plan view of a fifth embodiment of the tool of thisinvention, showing a modified guard section with a sunken floor.

FIG. 14A is a top plan view of a sixth embodiment of the tool of thisinvention, showing a modified guard section similar to the guard shownin FIG. 14, except including an opening along the slot for providingeasy access to the needle when inserting the needle into the implanteddevice.

FIG. 15 is a bottom plan view of the fifth embodiment of the tool ofthis invention shown in FIG. 14.

FIG. 16 is a perspective view illustrating a nurse using a tool similarto that shown in FIG. 14A to remove a needle from an implanted medicaldevice, except modified to facilitate using the tool for both accessingand deaccessing the needle.

FIG. 17 is a perspective view similar to that shown in FIG. 16 where thenurse is using the tool shown in FIG. 16 to access a needle into animplanted medical device.

FIG. 18 is a perspective view of a seventh embodiment of the tool ofthis invention which is similar to that shown in FIG. 17, exceptmodified to so that the handle and guard sections are detachable.

FIG. 19 is a plan view of the tool shown in FIG. 18 showing the handleand guard sections detached.

FIG. 20 is a side elevational view of the detached handle sectionillustrated in FIG. 18.

FIG. 21 is a side elevational view of the detached guard sectionillustrated in FIG. 18.

FIG. 22 is a sectional view taken along line 22—22 of FIG. 21.

FIG. 23 is a perspective view of an eight embodiment of the tool of thisinvention looking at the topside of the tool.

FIG. 24 is a perspective view of the tool shown in FIG. 23 looking atthe underside of the tool.

FIG. 25 is a plan view of the topside of the tool shown in FIG. 23.

FIG. 26 is a side elevational view taken along line 26—26 of FIG. 25.

FIG. 27 is a cross-sectional view taken along line 27—27 of FIG. 25.

FIG. 28 is a plan view of the underside of the tool shown in FIG. 23.

FIG. 29 is a front elevational view of the tool shown in FIG. 23.

FIG. 30 is a cross-sectional view taken along line 30—30 of FIG. 26.

FIG. 31 is an enlarged fragmentary view of a receptacle opening in theside wall of the tool shown in FIG. 23.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Prior Art

As illustrated in FIGS. 1 and 2 a conventional vascular access device 10has been implanted in the conventional manner under the skin 12 of apatient. As best shown in FIG. 3, this vascular access device 10includes a housing 14 having an inlet 16 sealed by a latex seal 18.There is an outlet 20 in the device 10 remote from the inlet 16 with afluid retention chamber 22 between the inlet and outlet. A tube 24connected to the outlet 20 is inserted using a catheter (not shown) intoa vein 26 of the patient.

A non-coring needle 30 is employed to administer medication through thevascular access device 10. The needle 30 has a generally 90 degree anglebend with one end of the needle being in communication through a tube 32with the medication (not shown). A pair of flexible wings 34 extendoutward from a hub 36. The nurse grasps these wings 34 when inserting orremoving the needle 30 from the vascular access device 10. The shaft 30a of the needle 30 extends through the patient's epidermal layer of skin12 and penetrates the seal 18, with the tip 30 b of the needle enteringthe chamber 22. The medication flows through the needle 30 into thechamber 22 and then out the chamber through the tube 24 into thepatient's vein 26. When the needle is removed as illustrated in FIG. 1,there sometimes occurs an involuntary recoil of the nurse's hand as sheor he withdraws the needle from the seal 18 and skin 12. This oftenhappens when exudate from the wound produced by insertion of the needle30 hardens or the needle is left in the device for a number of days. Therecoil many times results in the nurse being stuck with the needle. Sucha needle stick can result in infection with AIDS, Hepatitis B, or otherblood borne infectious diseases.

First Embodiment

In accordance with this invention, a tool 40 is employed to removesafely the needle 30 from the vascular access device 10.

As best illustrated in FIGS. 4 through 7, this tool 40 includes a handlesection 42 and an enlarged guard section 44 connected by an intermediateneck section 46. The intermediate neck is at an acute angle of about 35degrees with respect to the guard section 44, and at an acute angle ofabout 15 degrees with respect to the handle section 42. The area of theguard section 44 is in excess of 1.25 square inches, and in theembodiment illustrated has an area of 3-4 square inches. The guardsection 44 has the general configuration of a spatula with the guardsection 44 providing a shield which covers or overlies the skin areaadjacent the vascular access device 10. The tool 40 includes a forwardedge 48 which preferably is beveled or tapered. At the opposed ends ofthis forward edge 48 are side edges 50 and 52 which extend rearwardtoward the handle section 42. There is an elongated slot 50 whichextends from the forward edge 48 rearward towards the handle section 42and terminates at a bite 54 which acts as a stop.

As best shown in FIGS. 4 and 5, the nurse grasps the handle section 42with the left hand, if their dominant hand is the right hand, placingthe thumb in a thumb depression 56 (FIGS. 5 and 6) in the handlesection. The tool 40 is positioned next to the needle 30, and movedtowards the needle, sliding the slot 50 along the shaft 30 a of theneedle until the shaft abuts the bite 54 of the slot. The nurse pressesgently downward against the surface of the skin 12 with the generallyflat, smooth underside 60 (FIG. 7) of the guard section 44, pressingagainst the surface of the skin to prevent the vascular access device 10from moving while the needle 30 is being slowly lifted from the devicewhile maintaining the needle generally at a right angle with respect tothe seal 18. With the dominant right hand, the nurse grasps the wings34, pressing them together, and withdraws the needle 30 outward and awayfrom the device 10 with a smooth steady motion. If there is a recoil,the guard section 44 prevents the needle 30 from sticking the patientand, because the left hand is now remote from the vascular access device10, being at least 3 inches away from the needle when lodged in thedevice 10, it is virtually impossible for the nurse to stick him orherself with the needle 30 upon withdrawing the needle from the device.Although the thumb depression 56 serves to position the left hand of thenurse a safe distance away from the needle 30 lodged in the device 10, amark 62 (FIG. 6) may also be used to indicate the proper hand position.If the thumb depression 56 is eliminated, such a mark 62 indicates tothe nurse that his or her hand should remain placed behind this mark onthe side of the mark furthest away from the needle 30.

The tool 40 preferably is made of a transparent material such aspolycarbonate plastic which enables the tool to be injection molded, andtherefore inexpensively mass produced. The tool 40, particularly whenthe guard section 44 is made of a transparent material, may be used toinsert the needle into the vascular access device 10. In this case ofaccessing the device 10, the nurse first locates the implanted device 10by palpating the skin 12, and then tool 40 is placed over the implanteddevice and pressed downward against the skin 12 overlying the device 10,to steady the device while the needle is inserted through the slot 50into the skin 12 and seal 18.

The dimensions of this tool are very important to ensure the proper safeperformance of the device. These dimensions are set forth in thefollowing table with references to FIG. 6.

TABLE I ITEM DIMENSION RANGE l₁ 0.5 inch-3 inch l₂ 3 inch-8 inch l₃ 1inch-6 inch l₄ .5 inch-5 inch l₅ 0.25 inch-2{fraction (13/16)} inch

Second Embodiment

Also in accordance with this invention, there is provided as shown inFIGS. 8 through 10 a specially designed tool 70 for safely inserting theneedle 30 into the vascular access device 10. Although this procedure isnot as dangerous, because the needle 30 is ordinarily sterile, a needlestick may under some circumstances cause transmission of disease. Thus,it is highly desirable to avoid a needle stick when accessing theimplanted device 10.

The accessing tool 70 comprises an elongated body 72 having a holdersection 74 attached to a handle section 76. The holder section 74includes two outwardly extending fork elements 78 and 80 which arespaced apart a distance equal to the width of the vascular accessingdevice 10. Preferably there is a thumb depression 56 in the handlesimilar to that illustrated in connection with the tool 40 to insuremaintaining the safe distance away from the needle 30 as it is insertedinto the implanted device 10.

As best shown in FIG. 8, the nurse holds the accessing tool 70 in theleft hand while grasping the wings 34 of the needle 30 with the righthand. The nurse pushes the tip 30 b of the needle 30 through the layerof skin 12 into and through the latex seal 18. Simultaneously, theholder section 74 is placed over the skin, with the forks 78 and 80straddling the vascular accessing device 10, enabling the nurse to holdthe device steady and virtually immovable while the needle 30 is beinginserted into the device.

The important dimensions of the accessing tool are set forth in thefollowing table with reference to FIGS. 9 and 10.

TABLE II ITEM DIMENSION RANGE l₆ 1 inch-6 inch l₇ 0.5 inch-3 inch l₈ ½inch-2 inch l₉ ½ inch-3 inch l₁₀ 1½ inch-5 inch

Third Embodiment

As illustrated in FIG. 11, the tool 40 has been modified so that thelength of slot 50 a is substantially shorter than shown in FIG. 6. Theuse of such a short slot 50 a may be desirable in certain applications,such as deaccessing a difficult to remove embedded needle. The shorterslot 50 a may be used as a wedge to pry the needle up and off of thepatient's skin.

Fourth Embodiment

The fourth embodiment includes a tool 40 a with a circular shaped guardsection 44 a. In FIG. 12, the slot 50 c is curved inward from a portionof the edge of the guard section 44 a near the handle section 42 a. Thistool 40 a is used with the left hand. This fourth embodiment alsoincludes a tool 40 b with a circular shaped guard section 44 b. In FIG.13, the slot 50 d is curved inward from a portion of the edge of theguard section 44 b near the handle section 42 b. This tool 40 b is usedwith the right hand.

Fifth Embodiment

As illustrated in FIGS. 14 and 15, the fifth embodiment includes a tool100 with a modified guard section 102. The guard section 102 employs arecessed floor 104. This floor 104 has a wall 106 attached to its rearend and a side wall 108 along each side edge of the floor. The sidewalls 108 merge with the rear wall 106 to partially enclose the floor.Only the forward edge 110 of the floor 104 is free for use in accessingor deaccessing the needle 30. The side walls 108 preferably taperdownward from their highest elevation at the rear wall 106 towards theforward edge 110.

There is a slot 112 extending from the forward edge 110 towards thecentral section of the floor. The edges 112 a of the slot 112 and theforward edge 110 are beveled or tapered. Such a taper assist the nursein wedging the tool 100 underneath the needle 30 inserted and sometimesflush against the skin 12. When the needle is difficult to remove, thesetapers edges of the forward edge and slot serve as a wedge to lift theneedle up slightly off the surface of the skin.

Sixth Embodiment

As depicted in FIGS. 14A, and 16 and 17, the tool 100 has been modifiedto better enable it to be used for both accessing and deaccessing theneedle 30. The principal difference between the tool 100 and the sixthembodiment of this invention, the tool 150, is that the slot 112 hasalong its length about midway between the forward edge 110 and the bite152 of the slot, an enlarged open portion 154 encircled by a dottedcircular red line 156. This circular line 156 has its center coincidentwith the center of the enlarged open portion 154. The guard section 102of the tool 150 is made of a transparent material.

As illustrated in FIG. 16, the tool 150 is used to deaccess the needlealready inserted into the device 10 by positioning the guard section 102so that the needle shaft 30 a abuts the bite 152 of the slot 112. Asdiscussed above, the nurse then grasps the wings 34 of the needle 30 andwithdraws the needle from the vascular accessing device 10. Asillustrated in FIG. 17, to use this same tool 150 for accessing theneedle 30, the nurse first palpates the skin 12 to locate the device 10.Then the nurse positions the tool 150 with the guard overlying theimplanted device. Because the guard section 102 is transparent, this ismore readily accomplished than when using a guard of opaque material.The nurse uses the circular dotted red line as a sighting mechanism,bring the guard section into a position where the center of theimplanted device 10 is coincident with the center of the enlarged openportion 154. The nurse then directs the needle through the open portion154, and into the skin and device. The needle 30 is aligned at an angleof about 90 degrees with respect to the surface of the skin 12. Becausethe open portion 154 is substantially larger than the diameter of theneedle 30, the nurse will be able to move the needle through the openportion 154 without touching the guard member, thereby avoidingcontaminating the needle. Typically, the area of the open portion 154 isgreater than 0.0036 square inch, and is circular having a diametergreater than {fraction (1/16)} inch.

Seventh Embodiment

The seventh embodiment depicted in FIGS. 18 through 22 illustrate anaccessing and deaccessing tool 180 which has a guard section 182detachably connected to a handle section 184. Preferably, the guardsection 182 is made of an inexpensive, transparent material, and issterile prior to use and may be discarded after use. The handle section184 preferably is made of an opaque, durable material and may be reusedseveral times.

The handle section 184 has an elongated handle 184 a with a thumbdepression 210 in an intermediate portion. A tongue 212, integral withthe forward end of the handle 184 a, and having a generally rectangularconfiguration with a width slightly less than the width of the guardsection, serves as the connector for attaching the handle section 184 tothe guard section 182. The back end 212 a of the tongue 212 ischamfered, and as will be discussed in greater detail subsequently,interacts with a tab 204 on the guard section 182 when the handle andguard sections engage.

The guard section 182 (FIG.18) is similar to the guard section 102 (FIG.16) of the tool 150. It has an elongated slot 186 extending inward thatterminates in an enlarged circular opening 188 that is aligned with thevascular access device 10 when the tool is to be used to access thevascular access device. The leading edges 190 and sides 192 of the slot186 and opening 188 are tapered to assist in slipping the guard section182 under a needle 30 in the vascular access device 10 when the tool 180is used for deaccessing the needle 30. The lateral sides 194 and 196(FIG. 22) are raised and each has an inwardly directed lip 194 a and 196a, respectively. These lips 194 a and 196 a serve as tracks for holdingthe handle section 184 upon attaching the handle section to the guardsection 182. There is a stop member 198 (FIG. 19) between the inwardends of the lips 194 a and 196 a and the circular opening 188 thatlimits the inward movement of the handle section 184.

As best illustrated in FIGS. 19 and 22, at the rear 182 a (FIG. 19) ofthe guard section 182 the tab 204 that engages the handle section 184upon inserting the tongue 212 of the handle section under the tracksprovided by the lips 194 a and 196 a. This tab 204, which is manuallyreleased by depressing it, is integral with the rear 182 a of the guardsection 182 and pivots along a hinge formed along the line of connectionwith the rear 182 a of the guard section 182. When depressed, the tab204 is moved downward to allow the tongue 212 to be slipped beneath thelips 194 a and 196 a until the forward end 212 b of the tongue engagesthe stop member 198. Upon release, it springs back into its normalposition depicted in solid lines in FIG. 21 to grasp the chamfer edge212 a of the tongue 212 of the handle section 184. To disconnect thehandle section 184, the tab 204 is manually depressed and the handlesection is simply pulled away from the guard section 182, with thetongue 212 sliding along the lips 194 a and 196 a until clear. Thus, thetab 204 and chamfer edge 212 a provide a locking mechanism which ismanually released.

Eighth Embodiment

As illustrated in FIGS. 23 through 30, the eighth embodiment of thisinvention, the tool 300, has a guard 302 attached to a handle 304. Thistool 300 is made from a polypropylene homopolymer that is injectedmolded using conventional molding techniques to form a unitary structureabout 5-6 inches long and about an inch wide. The guard 302 has agenerally circular configuration with a diameter of one inch. Thecircumferential edge 306 of the guard 302 is beveled inwardly to allowthe guard to be forced beneath the needle 30 when the tool 300 is beingused to deaccess the needle from the implanted vascular access device10. The guard 302 has a slot 308 which extends from the circumferentialedge 306 inwardly and radially, terminating in an enlarged, circularopening 308 a which has its center coincident with the center of theguard 302. The diameter of the circular opening 308 a is about ¼ inch.The opposed sides 308 b of the slot 308 are beveled inwardly.

As best shown in FIG. 24, the underside 302 a of the guard 302 has acentral depression in the form of a C-shaped, concave section 310. Thediameter of this concave section is about ½ inch, which correspondsapproximately to the outside diameter of the top portion of theimplanted vascular access device 10. As best shown in FIG. 28,surrounding this concave section 310 is a flat peripheral bottom,comprising a pair of approximately semi-circular sections 312 a and 312b which straddle the slot 308. The depth of the concave section 310 atits center is about {fraction (3/16)} inch. Optionally, indicia may beplaced on the guard 302 to assist in aligning the circular opening 308 awith the implanted vascular access device 10 during accessing anddeaccessing.

The handle 304 is uniquely shaped to provide a reinforced structure thatprevents the handle from twisting or bending when used in a normalfashion. One unique characteristic of the handle 304 is a raised thumblever 314 approximately 2 ½ inches from the center of the enlargedopening 308 a. This thumb lever 314 serves as a marker indicating thatthe hand of the nurse should be behind this thumb lever. A pair ofopposed, triangular, reinforcing pieces 316 at the rear of the guard 302are integral with the handle 304 at the point where a top wall 304 a ofthe handle 304 and opposed side walls 304 b of the handle merge with therear of the guard. The forward portion of the top wall 304 a slopesdownward from the apex 314 a of the thumb lever 314 towards the guard302, changing its direction of curvature, and then merges with the rearof the guard. The rearward portion of the top wall 304 a slopes downwardfrom the apex 314 a of the thumb lever 314, then substantially flattensinto an elongated portion that terminates at the end of the handle 304.The opposed side walls 304 b are approximately of the same height andare substantially at a right angle to the top wall 304 a. There is arear wall 304 c closing off the end of the handle 304, which is also ata substantially right angle with respect to the top wall 304 a. Thejunction where the side walls 304 b and rear wall 304 c intersect withthe top wall 304 a are beveled, and the inside edges of the side wallsand rear wall are beveled inwardly.

As shown in FIG. 26, the underside 302 a of the guard 302 and theforward portion of the top wall 304 a after changing its direction ofcurvature form a connector section 303. The front face of this connectorsection 303 and the underside 302 a of the guard 302 form an angle ofabout 80 degrees. This assist in creating a downward force applied tothe guard 302 when the nurse applies a downward pressure when graspingthe handle and positioning her or his thumb against the thumb lever 314,The polypropylene is transparent or translucent, allowing the nurse toposition the guard 302 in an overlying position with respect to theimplanted vascular access device 10, allowing the nurse to push with thethumb against the thumb lever 314, so that a substantial downwardcomponent of force is applied by the guard against the skin 12 overlyingthe implanted device 10. The upper portion of the implanted device 10,along with the overlying skin 12, seats itself within the concavesection 310 of the guard 302 when this downward force or pressure isapplied through the tool 300 to the implanted device.

As best shown in FIG. 31, the tool 300 has a receptacle 320 in the sidewall 304 b comprising a hole 322 defined by the ends of a series ofradial teeth 324. This hole 322 has a diameter which is slightly lessthan the diameter of the needle 30 withdrawn from the implanted device10. The nurse inserts the tip of the withdrawn needle 30 into the hole322. As the tip of the needle 30 is pushed into the hole 322, the teeth324 bend inward and grasp the needle, holding the needle securely withinthe receptacle 320, so that it is not easily dislodged from thereceptacle. Thus, the tool 300, with the needle 30 captured in thereceptacle 320, may be discarded safely.

General Procedures

Conventional aseptically clean techniques are followed in using thetools and methods of this invention, and the needle 30 is flushed withsaline and Heparin solutions to avoid clogging. Clean or sterile rubbergloves should be worn when accessing and deaccessing the needle 30, andall used needles 30 are disposed of in sharps safety containers, orsafely by inserting in the receptacle 320, and then placed in a sharpssafety container.

SCOPE OF THE INVENTION

The above presents a description of the best mode contemplated ofcarrying out the present invention, and of the manner and process ofmaking and using it, in such full, clear, concise, and exact terms as toenable any person skilled in the art to which it pertains to make anduse this invention. This invention is, however, susceptible tomodifications and alternate constructions from that discussed abovewhich are fully equivalent. Consequently, it is not the intention tolimit this invention to the particular embodiments disclosed. On thecontrary, the intention is to cover all modifications and alternateconstructions coming within the spirit and scope of the invention asgenerally expressed by the following claims, which particularly pointout and distinctly claim the subject matter of the invention.

What is claimed is:
 1. A tool for assisting in accessing and deaccessinga needle, including an elongated body having a handle section with alength of 3 inches or more and an enlarged guard section made of atransparent material and having an area of 1.0 square inch or more, saidhandle section having a marker indicating that a hand of the nurseshould be behind said marker, said marker being located to position thehand of the nurse at least 2.5 inches away from the needle during use,and an elongated slot extending from an edge of the guard section intothe guard section, terminating at an internal portion of the guardsection.
 2. The tool of claim 1 where said guard section has a forwardedge terminating at opposed ends, side edges at each opposed end whichextend rearward to said handle section, and said elongated slotextending from the forward edge rearward towards said handle section,said forward edge having a length of from 1 to 6 inches, said side edgeshaving a length of from 0.5 to 3.0 inches, and said slot having a lengthof from 0.25 to 3 inches.
 3. The tool of claim 2 where the slot is at aright angle with respect to the forward edge.
 4. The tool of claim 2where the minimum distance between the slot and a side edge is {fraction(3/16)} inch and the maximum distance between the slot and a side edgeis 3 inches.
 5. The tool of claim 1 where the slot has a width of from{fraction (1/16)} to ¼ inch.
 6. The tool of claim 1 where the slot andthe handle section are in substantial alignment with each other, bothlying along a common longitudinal axis.
 7. The tool of claim 1 where theguard section has a thickness of from {fraction (1/32)} to {fraction(3/16)} inch.
 8. The tool of claim 1 where handle section includes anintermediate neck section, and said guard section is joined to theintermediate neck, said handle section and said intermediate neck beingat an acute angle of from 0 to 20 degrees, and said intermediate necksection and said guard section being at an acute angle of from 10 to 40degrees.
 9. The tool of claim 1 where guard section has a smooth,generally planar underside surface.
 10. The tool of claim 1 where theelongated body has a length of from 3 to 11 inches.
 11. The tool ofclaim 1 where the slot has tapered edges.
 12. The tool of claim 1 wherethe marker comprises a raised thumb lever.
 13. The tool of claim 1 madefrom an injected molded polymeric material.
 14. The tool of claim 13where the polymeric material is a polypropylene or polycarbonate. 15.The tool of claim 1 where the handle section has an elongated depressiontherein extending lengthwise along said handle section.
 16. The tool ofclaim 1 where the guard section has a pair of marks thereon space aparta distance approximately equal to the width of an implanted medicaldevice.
 17. A tool for accessing and deaccessing a needle used with amedical device of a predetermined configuration and implanted under theskin of a patient, including an elongated body including a handlesection and an enlarged guard section, said guard section having an areaof 1.0 square inch or more, an edge, and an underside with a depressionhaving a configuration substantially the same as the configuration ofthe medical device, so that when the guard section overlies theimplanted medical device and is pressed against said implanted medicaldevice, the skin of the patient and at least a portion of the medicaldevice are received in said depression, an elongated slot which extendsfrom the edge of said guard section and terminates in the guard sectionat in an enlarged open portion through which a needle is inserted whenaccessing the implanted medical device.
 18. The tool of claim 17 wherethe enlarged open portion has an area in excess of 0.0036 square inch.19. The tool of claim 17 where there is indicia at least partiallyencompassing the enlarged open portion which assist the nurse to alignthe open portion with the implanted medical device.
 20. The tool ofclaim 17 where the handle has a connector section that is attached tothe guard section, with said connector section and guard section form anangle of 60 degrees or more.
 21. The tool of claim 20 where the angle isbetween 60 and 90 degrees.
 22. A method for manually removing a needlefrom a medical device implanted under the skin of a patient, includinggrasping with one hand a handle section of a tool having a guard sectionhaving an area of 1.00 square inch or more and a slot therein, slidingthe slot along the needle to bring the guard section into an overlyingrelationship with the implanted medical device, maintaining said onehand a minimum distance away from the needle of at least 2.5 inches, andwith the other hand withdrawing said needle free of the implantedmedical device.
 23. The method of claim 22 where the guard section ismade of a transparent material.
 24. The method of claim 22 where thetool includes an elongated body having the handle section attached tothe guard section, said guard section having a forward edge terminatingat opposed ends, side edges at each opposed end which extend rearward tosaid handle section, and an elongated slot which extends from theforward edge rearward towards said handle section, said forward edgehaving a length of from 1 to 6 inches, said side edges having a lengthof from 0.5 to 3 inches, and said slot having a length of from 0.25 to 3inches.
 25. The method of claim 22 where said slot has a width that isslightly broader than the diameter of the needle.
 26. The method ofclaim 22 where the tool has an elongated body having a length of from 4to 11 inches, said body including the handle section having a length offrom 3 to 8 inches and an enlarged guard section having a length of from0.5 to 3 inches, said guard section having a forward edge having alength of from 1 to 6 inches, said forward edge terminating at opposedends in side edges which extend rearward to said handle section, saidside edges having a length of from 0.5 to 3 inches, an elongated slot inthe guard section which extends from the forward edge rearward towardssaid handle section and has a width of from {fraction (1/16)} to ¼ inchand a length of from 0.25 to 3 inches, said slot being at a right anglewith respect to the forward edge, with the slot and the handle sectionbeing in substantial alignment with each other, both lying along acommon longitudinal axis, the minimum distance between said slot and theside edges being {fraction (3/16)} inch and the maximum distance betweenthe slot and the side edges being 3 inch.
 27. A method for manuallyinserting a needle into a medical device implanted under the skin of apatient, including (a) grasping with one hand a tool with a holdersection and a handle section, and holding the tool by the handle sectionand pressing the holder section against the skin overlying the medicaldevice, (b) gripping the needle with the other hand and inserting saidneedle through said skin into the medical device, and (c) maintainingthe one hand a distance of at least 2.5 inches away from the needle assaid needle is inserted into the medical device.
 28. The method of claim27 where said tool includes a handle section attached to the holdersection, and said holder section has a pair of fork elements spacedapart a distance which is slightly greater than the width of the medicaldevice.
 29. The method of claim 27 where the fork elements are of equallength, each having a length of from 0.5 to 3 inch, and the holdersection has a length of from 1.5 to 5 inches and the handle section hasa length of from 3 to 8 inches.
 30. The method of claim 27 where thetool is made from an injected molded polymeric material.
 31. A methodfor manually inserting a needle into a medical device implanted underthe skin of a patient, including (a) grasping with one hand a tool witha transparent holder section with an open section therein providingaccess to the patient's skin through which said needle is passed as saidneedle is inserted through said skin into the medical device, said guardsection having indicia thereon for assisting in aligning the guardsection with the implanted medical device, said tool including anelongated body including a handle section and an enlarged guard section,said guard section having a floor made of a transparent material andhaving an area of from 1.00 square inch to 18 square inches, said floorhaving a rear end to which the handle section is attached, opposedsides, and a forward edge, an elongated slot which extends from theforward edge rearward towards said handle section and terminates at anend at least 0.5 inches from the forward edge, said slot beingsubstantially at a right angle with respect to the forward edge, withthe slot and the handle section being in substantial alignment with eachother, both lying along a common longitudinal axis, and said slot havingbetween the forward edge and the end of the slot a n enlarged openportion with an area in excess of 0.0036 square inch through which aneedle is inserted when accessing the implanted medical device, saidhandle section having a marker thereon indicating that a hand of thenurse should be behind said marker, said marker being a distance toposition the hand of the nurse at least 2.5 inches away from the needleduring use, (b) gripping the needle with the other hand, said other handbeing behind the marker, and inserting said needle through said skininto the medical device, and (c) aligning the guard section with theimplanted medical device, using the indicia to bring the guard sectioninto an overlying relationship with the implanted medical device withthe open section being approximately over the central section of theimplanted medical device, and (d) pressing the holder section againstthe skin overlying the medical device, covering the skin to maintainsaid one hand a safe distance away from the needle as said needle isinserted into the medical device.
 32. A tool for accessing anddeaccessing a needle, including an elongated body including a handlesection and a guard section, said guard section having an area of 1.0square inches or more, an edge, and an underside with a concave sectionhaving a substantially circular rim with a diameter of from {fraction(1/16)} to ½ inch, and a depth of from {fraction (1/16)} to {fraction(3/16)} inch, an elongated slot which extends radially outward from thecenter of the concave section to the edge of said guard section.
 33. Thetool of claim 32 where the slot terminates in the guard section at in anenlarged open portion.
 34. The tool of claim 33 where the enlarged openportion has an area in excess of 0.0036 square inch.
 35. The tool ofclaim 32 where there is indicia at least partially encompassing theenlarged open portion which assist the nurse to align the open portionwith the implanted medical device.
 36. The tool of claim 32 where thereis a receptacle member on said body in which a needle may be inserted.37. A tool for accessing and deaccessing a needle, including anelongated body including a handle section and a guard section moldedfrom a polymeric material as a unitary structure, said guard sectionhaving a substantially circular configuration with a center and an areaof 1.0 square inch or more and an underside with a concave sectionhaving a center coincident with the center of the guard section and asubstantially circular rim with a diameter of from {fraction (1/16)} to½ inch, and a depth of from {fraction (1/16)} to {fraction (3/16)} inch,and an elongated slot which extends radially outward from the center ofthe concave section to an edge of said guard section.
 38. The tool ofclaim 37 where the slot terminates in the guard section at in anenlarged open portion having an area in excess of 0.0036 square inch.39. The tool of claim 37 where there is a marker on the handle sectionindicating that a hand of the nurse should be behind said marker, saidmarker being located to position the hand of the nurse at least 2.5inches away from the center of the concave section.
 40. The tool ofclaim 37 where the handle section has top wall and side walls extendingfrom the top wall substantially at a right angle with respect to the topwall, and the marker comprises a raised portion on the handle thatserves as thumb lever.
 41. The tool of claim 37 where the edge of saidguard section is beveled.
 42. The tool of claim 37 where the handle hasa connector section that is attached to the guard section, with saidconnector section and guard section form an angle of 60 degrees or more.43. The tool of claim 42 where the angle is between 60 and 90 degrees.